A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Melanoma (Skin)
- Sponsor
- Herbert Irving Comprehensive Cancer Center
- Locations
- 1
- Last Updated
- 12 years ago
Overview
Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of recombinant vaccinia-TRICOM vaccine in patients with metastatic melanoma. * Determine the clinical toxic effects of this vaccine in these patients. * Determine the safety of this vaccine in these patients. * Determine the clinical response of these patients to this vaccine. * Determine evidence of host anti-melanoma immune reactivity in these patients after treatment with this vaccine. OUTLINE: This is a dose-escalation study. Patients receive recombinant vaccinia-TRICOM vaccine once every 4 weeks for a total of 3 vaccinations. Patients with stable or responding disease may receive an additional course of vaccinations. Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Quality of life is assessed at baseline, at each vaccine administration, and at study completion. Patients are followed at 3 months. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 6-12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified